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Dying? No Risky Drugs For You! Texas Faces The Reality Of Inaccessible Experimental Drugs

Aug 22, 2007
Apparently, one's schedule of death is more of the court's business than most would believe. On August 7th, the Court of Appeals for the District of Columbia Circuit ruled against terminally ill patients' right to try experimental drugs in an effort to save their own lives.

Judge Thomas B. Griffith said the freedom to use medications not approved by regulatory bodies was not rooted in the traditions and history of the United States, and therefore could not be legally sanctioned. Self-defense clauses in the Bill of Rights "cannot justify creating a constitutional right to assume any level of risk without regard to the scientific and medical judgment expressed through the clinical testing process," said Griffith.

For states like Texas, this is big news. Chronic diseases like diabetes are on the rise, without a definitive cure in sight. While not officially classified as a terminal illness, diabetes was listed as the sixth leading cause of death in the state; its incidence increased twenty-seven percent in Texas in just five years -- from 2000 to 2005. Approximately 1.3 million adults throughout Dallas, Austin, Houston and the rest of the state are currently diagnosed, and potentially fatal complications include cardiovascular disease (the number one killer of Americans), stroke, and hypertension. Amputations, eye disease, and chronic infections also occur.

Overall, a person with diabetes has a seventeen percent greater chance of being diagnosed with cardiovascular disease, an eight percent higher likelihood of suffering a stroke, and is forty-three percent more likely to develop hypertension. If terminally ill patients cannot gain access to experimental treatments without being one of the lucky ones included in certain stages of clinical trials, then it can be assured that those with chronic illnesses, no matter the level of associated complications, will also be denied.

Perhaps even more striking, sufferers of lung cancer (which is also a problem in Texas), HIV/AIDS, and multiple sclerosis would also be denied the choice, even though current treatment options either offer no cure, or only save a small minority of those diagnosed.

Most health insurance companies won't cover experimental treatments, but for many dying of an as-of-yet incurable illness, this is simply not the issue. It's that, coverage or no coverage, with or without the ability to pay, a drug that could save lives may exist, and may exist in enough quantity to provide treatment -- but still -- very few actually have access to it. With the only other option being death, many would rather take the risk of trying something.

The recent controversies over Vioxx, an arthritis medication found to increase the risk of certain heart problems, Avandia, a diabetic treatment believed capable of producing similar negative side effects, and Prilosec and Nexium, yet more seemingly innocuous drugs believed to increase the risk of heart attack and stroke, could call statements like Griffith's into even more question. If the Food and Drug Administration (FDA) has not always shown the best judgment in releasing, or warning against, possibly dangerous drugs, it may also prove true that the same agency is not allowing access to possibly life-saving medications when it should, either.

The Abigail Alliance for Better Access to Developmental Drugs first filed the case in 2003, challenging the FDA's right to restrict medications shown to have the potential of saving or prolonging the lives of terminally ill patients, but had not yet completed full clinical trials. Founder of the Abigail Alliance, Frank Burroughs, said the group was "dumbfounded that most of the justices tragically missed the merits of the case," and made promises to take the issue to the U.S. Supreme Court.

Burroughs, who lost his daughter, Abigail, to cancer after a lengthy battle to gain access to medications that were then classified as experimental but were later approved, believes such drugs should be accessible to terminally ill patients after the first of three phases of clinical trial.

Joined by the Washington Legal Foundation, the Abigail Alliance argued that denying these patients the right to use experimental medications violated the Fifth Amendment, which states that one cannot be deprived of the right to life, liberty, or property without due process of law. Blocking such access means sufferers can not enact an adequate level of self-defense, said the Foundation.

Judge Judith W. Rogers, one of only two judges in the Court of Appeals for the District of Columbia Circuit to rule for patients' right to choose, said it was "startling" that the "right to try to save one's life is left out in the cold, despite its [the 5th Amendment's due process clause] textual anchor in the right to life."

Opponents to open access to the medications, however, include more than just court officials. The National Organization for Rare Disorders, a patient advocacy group, responded by pointing out that drug companies would have less incentive to complete clinical trials to ensure the drugs were actually effective. There are reasons that not all experimental treatments hit the market.

The lifting of these restrictions would allow the industry to "profit from offering empty hope," said Robert Erwin of the Marti Nelson Cancer Foundation, another patient advocacy group.

Perhaps it simply comes down to a lack of faith -- in Americans' ability to make conscientious, high-stakes decisions about personal health. It's difficult to believe that the issue is actually a constitutional one; after all, we have the legal right to do a lot of things that aren't particularly good for us and, in fact, make absolutely no attempt to better our livelihoods. Drinking too much alcohol, smoking cigarettes, and eating horribly unhealthy food is, for instance, all sanctioned. In other words, as Americans, we seem to have the privilege of killing ourselves in a slow, painful way, but not of attempting unconventional means to do the opposite.

Being aware of political issues affecting your health is an important part of taking care of yourself. Minding your health will certainly affect you as you age, and eventually your wallet.
About the Author
Pat Carpenter writes for Precedent Insurance Company. Precedent puts a new spin on health insurance. Learn more at Precedent.com
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